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Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.

The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Titanium glenospheres are intended for patients with Cobalt Alloy material sensitivity. The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobalt alloy glenospheres. A Cobalt Alloy glenosphere is the recommended component for reverse shoulder arthroplasty patients without material sensitivity to cobalt alloy.

Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation.

Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

The devices are a line extension of the Comprehensive Reverse Shoulder System and consists of new 36mm and 40mm tray and liner locking mechanism designs as well a a new 40mm glenosphere. The highly cross-linked ultrahigh molecular weight (HXPE) polyethylene liners are offered either in Prolong® (Standard) or Vivacit-E (Vitamin E). The tray taper geometry as well as the material (Ti-6AL-4V and Co-28Cr-6Mo) and thickness offerings are identical (standard, +5mm, +10mm) to the predicate. The trays will still be offered with a centric (standard) taper as well as two other offset tapers (+3 and +6) to provide more offerings to the surgeon.

The provided document is a 510(k) summary for the Zimmer Comprehensive Reverse Shoulder System, which describes a medical device rather than an AI/ML algorithm. Therefore, many of the requested criteria related to AI/ML device performance (like experts for ground truth, adjudication methods, MRMC studies, training set details) are not applicable.

However, I can extract the relevant information regarding the device's acceptance criteria and the study (non-clinical testing) that proves it meets those criteria.

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly list "acceptance criteria" for each test with numerical thresholds. Instead, it states that non-clinical testing "demonstrated that the proposed devices meets performance requirements as defined by Design Control activities and is substantially equivalent to the predicate device in terms of safety and efficacy." The listed tests are the means by which this performance was evaluated.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document lists "Non-Clinical Tests," which typically involve physical models, simulations, or benchtop experiments rather than patient data. No sample sizes are specified for these non-clinical tests. Data provenance in terms of country of origin or retrospective/prospective is not applicable or provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as this is a mechanical device evaluation, not an AI/ML diagnostic or prognostic tool requiring expert ground truth for interpretation of patient data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically used for establishing ground truth in clinical studies involving interpretation of medical data, which is not the case here.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable, as this is a mechanical device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable, as standalone performance refers to AI algorithm performance without human intervention, which is irrelevant to a shoulder implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device would be established by engineering standards, validated testing methodologies, and comparison to the predicate device's established performance. It's based on objective physical and mechanical properties and behaviors, not clinical interpretations or pathological findings in the context of an AI/ML algorithm.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for physical device testing in the context of this 510(k) submission.

9. How the ground truth for the training set was established

Not applicable, as there is no training set mentioned or implied.

Ask a specific question about this device

The Comprehensive® Reverse Shoulder is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.

The Comprehensive® Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Titanium olenospheres are intended for patients with colbalt alloy material sensitivity. The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobalt alloy glenospheres. A cobalt alloy glenosphere is the recommended component for reverse shoulder arthroplasty patients without material sensitivity to cobalt alloy.

Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation.

Interlok® finish humeral stems are intended for cemented use and the Macro Bond® coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

The device is a single-use implant.

The Titanium Alloy Glenosphere Prosthesis consists of a series of various sized modular glenospheres with variable offset between 0.5mm and 4.5 mm. Titanium alloy material has been selected to provide the surgeon with an alternate material to treat patients with nickel allergies. Each modular glenosphere consists of a "head" and a taper adaptor. The taper adaptor is impacted into the head in a certain position to achieve the desired amount of offset. The system can be used with Biomet's Comprehensive® Reverse Shoulder System or Biomet's BioModular® Reverse Shoulder System.

This document is a 510(k) premarket notification for a medical device, specifically the Comprehensive® Reverse Shoulder - Titanium Glenosphere. It focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a study proving that the device meets specific acceptance criteria based on performance data.

Therefore, many of the requested sections about acceptance criteria, detailed study design, and performance metrics (like sample size for test sets, expert ground truth, effect size, etc.) are not applicable or not provided in this type of regulatory submission. The document explicitly states "No clinical data submitted" and "No clinical data was necessary for a determination of substantial equivalence."

However, I can extract the relevant information that is present:

1. A table of acceptance criteria and the reported device performance

Since this is a substantial equivalence submission, the "acceptance criteria" are implicitly defined by the characteristics and performance of the predicate devices. The performance reported here is primarily related to non-clinical bench testing.

Detailed Study Information (Not applicable/Not provided in this document type):

As noted, this document is a 510(k) summary demonstrating substantial equivalence, not a clinical study report with detailed performance data against specific acceptance criteria. Therefore, the following information is not present:

2. Sample sizes used for the test set and the data provenance: Not provided for this type of submission which relies on non-clinical testing for substantial equivalence. No clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there was no clinical test set requiring expert ground truth for this submission.
4. Adjudication method for the test set: Not applicable, as there was no clinical test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an orthopedic implant, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an orthopedic implant, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. "No clinical data submitted." For non-clinical tests (like torsional separation), the "ground truth" would be engineering specifications and predicate device performance.
8. The sample size for the training set: Not applicable. This device is an orthopedic implant, not an AI/algorithm that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

The Comprehensive® Reverse Shoulder is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.

The Comprehensive® Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation.

Interlok finish humeral stems are intended for cemented use and the MacroBond coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

The Comprehensive® Reverse Shoulder is intended for total shoulder replacement in a reverse shoulder configuration. Unlike traditional total shoulder replacement, a reverse shoulder employs a ball for articulation on the glenoid side of the joint and a polyethylene bearing surface on the humeral side of the joint. The glenoid baseplate features a medial boss through which a Central Screw is placed to hold the component in place. Additionally, there are four peripheral screw holes through the baseplate for screw fixation. The screws are available in both locking and non-locking styles. Both sterile and non-sterile versions of the screws will be marketed.

This 510(k) is for a design modification to the peripheral screws as well as the inclusion of non-sterile central and peripheral screw options to allow sterilization of the screws at the user facility in a screw caddy.

This document is a 510(k) premarket notification for the Comprehensive® Reverse Shoulder - Screws. It's a regulatory filing for a medical device, not a study evaluating an AI algorithm or diagnostic tool. Therefore, the information requested about acceptance criteria, study details, and AI performance is not applicable to this document.

Here's why each of your requested points cannot be answered from this document:

• 1. A table of acceptance criteria and the reported device performance: This document reports on a physical medical device (shoulder screws) and evaluates its substantial equivalence to a predicate device, primarily through non-clinical mechanical testing (Torque to Failure). It does not present performance data in the context of diagnostic accuracy, sensitivity, or specificity, which are typical for AI-based medical devices or diagnostic studies.
• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The "test set" here refers to the physical screws subjected to mechanical testing. There is no mention of data provenance in the context of patient data, as this is not a clinical study.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): "Ground truth" in this context would implicitly be the engineering specifications and performance limits for the screws, not established by medical experts for diagnostic purposes.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for mechanical testing of screws.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI device or a diagnostic reading study.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): As mentioned, the "ground truth" relates to mechanical engineering specifications and performance, not clinical outcomes or pathology from patient data.
• 8. The sample size for the training set: Not applicable, as there is no AI algorithm being trained.
• 9. How the ground truth for the training set was established: Not applicable, as there is no AI algorithm being trained.

In summary, this document is a regulatory submission for a physical orthopedic implant (screws for a shoulder replacement), not a study evaluating an AI device or diagnostic algorithm. Therefore, the requested information pertaining to AI performance and clinical study design for AI is not present. The document focuses on demonstrating that the modified screws are substantially equivalent to previously marketed screws based on design and non-clinical performance data (specifically torque to failure).

Ask a specific question about this device

The Comprehensive® Reverse Shoulder is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.

The Comprehensive® Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation.

Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

The Comprehensive® Reverse Shoulder is intended for total shoulder replacement in a reverse shoulder configuration. Unlike traditional total shoulder replacement, a reverse shoulder employs a ball for articulation on the glenoid side of the joint and a polyethylene bearing surface on the humeral side of the joint. This device configuration increases the lever arm of the deltoid muscle bundle to provide stability and the ability to raise the arm. This is especially useful in cases where a patient has a non-functioning rotator cuff which severely limits traditional joint replacement options.

The provided document is a 510(k) premarket notification for a medical device called the "Comprehensive® Reverse Shoulder - E1® Polyethylene Claims". It details the device's indications for use, regulatory classification, and claims related to its E1® Antioxidant Infused Technology.

Here's an analysis of the acceptance criteria and supporting studies, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• E1® GUR1020: Ultimate load (before/after aging) 97.2±6.4N / 100.0±5.0N. Ultimate tensile strength 45.8±1.6 MPa / 46.1±2.9 MPa. Yield strength 22.6±0.2 MPa / 22.8±0.3 MPa.
• E1® GUR1050: Ultimate load (before/after aging) 105.0±5.5N / 115.0±3.2N. Ultimate tensile strength 43±3 MPa / 43±2 MPa. Yield strength 24.2±0.2 MPa / 24.4±0.2 MPa. |

2. Sample Sizes Used for the Test Set and Data Provenance

The document describes material testing, not patient-level data. The "test sets" refer to the numbers of material specimens or samples used in the mechanical and chemical tests.

• Sample Size: Not explicitly stated as a single number. For Claim 3, ultimate loads are given with standard deviations (e.g., 105±5.5N), implying multiple samples were tested for each group, but the exact number of replicates is not provided. Similarly for Claim 4, multiple samples are implied. For Claims 1 and 2, it refers to "specimens" without numerical counts.
• Data Provenance: Not applicable in the context of patient data. The tests are bench tests conducted on materials. The "provenance" refers to the specific materials (GUR1020 and GUR1050 UHMWPE) and their processing methods (isostatically compression molded, crosslinked, gamma irradiation, vitamin E infusion, etc.). It's a laboratory-based study.
• Retrospective/Prospective: Not applicable. These are in-vitro, bench-top material tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This document details material properties and performance through standardized mechanical and chemical testing, not expert interpretation of clinical data. The "ground truth" is established by the results of these physical tests, which are objective measurements.

4. Adjudication Method for the Test Set

Not applicable. This refers to consensus-building among experts for ambiguous cases in clinical studies. For material performance tests, observations (like presence/absence of cracks, oxidation indices, ultimate load measurements) are objective and do not require expert adjudication to establish truth.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is a material science study to evaluate the properties of polyethylene used in a shoulder prosthesis, not an AI-based diagnostic or assistive device. There are no human readers or AI involved in interpreting the results.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a material science study, not an algorithm or AI performance evaluation.

7. The Type of Ground Truth Used

The ground truth is established by objective measurements and observations from validated laboratory tests on material samples. Examples include:

• Absence of environmental stress cracking (visual inspection/microscopy).
• Oxidation indices from infrared spectroscopy (quantitative chemical analysis).
• Ultimate load measurements from small punch testing (quantitative mechanical test).
• Ultimate tensile strength and yield strength from tensile testing (quantitative mechanical test).

These are direct physical and chemical properties of the material, measured using established scientific methods, rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" in these material performance studies. The tests are conducted on representative samples of the manufactured material to evaluate its inherent properties.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set.

Ask a specific question about this device

The Comprehensive® Reverse Shoulder is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.

The Comprehensive® Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation.

Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

The Comprehensive® Reverse Shoulder is intended for total shoulder replacement in a reverse shoulder configuration. Unlike traditional total shoulder replacement, a reverse shoulder employs a ball for articulation on the glenoid side of the joint and a polyethylene bearing surface on the humeral side of the joint. This device configuration increases the lever arm of the deltoid muscle bundle to provide stability and the ability to raise the arm. This is especially useful in cases where a patient has a non-functioning rotator cuff which severely limits traditional joint replacement options.

This document describes a 510(k) premarket notification for the "Comprehensive® Reverse Shoulder - Mini Baseplate" device. The submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (Comprehensive® Reverse Shoulder, 510(k) K080642), rather than establishing new acceptance criteria for a novel device. Therefore, the information typically associated with acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML or diagnostic device is not directly applicable here.

However, I can extract the relevant information regarding the performance data section and how substantial equivalence was demonstrated for this medical device, which serves a similar purpose of proving the device's safety and effectiveness compared to an existing standard.

Here's a breakdown of the available information structured to best fit your request:

1. Table of Acceptance Criteria and Reported Device Performance

In the context of this 510(k) submission for a medical implant, "acceptance criteria" refers to demonstrating that the new device (Mini Baseplate) performs equivalently to the predicate device in terms of mechanical properties and materials, ensuring it is safe and effective for its intended use. The table below summarizes the comparison to the predicate device. Specific numerical acceptance criteria are not explicitly stated as pass/fail thresholds in this summary but are implied by the statement "performed within the intended use" and "did not raise any new safety and efficacy issues."

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated. For mechanical testing of medical devices, sample sizes are typically determined by relevant ISO or ASTM standards (e.g., n=5 or n=6 per group for certain tests), but the exact numbers are not provided in this summary.
• Data Provenance: The tests are non-clinical (mechanical bench testing). Therefore, there is no "country of origin of the data" in the human data sense, nor is it retrospective or prospective. The data is generated in a laboratory setting.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable to this type of submission. "Ground truth" in this context would refer to the physical and mechanical properties of the materials and device components. The "truth" is established by standard engineering principles and validated testing methods according to recognized standards.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 typically refer to human expert judgment in clinical or diagnostic studies. This submission relies on objective mechanical testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and AI assistance can potentially improve their performance. This submission is for a surgical implant, not a diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

No, a standalone algorithm performance study was not done. This point is relevant for AI/ML diagnostic tools.

7. Type of Ground Truth Used

The "ground truth" for non-clinical performance data for an orthopedic implant like this is based on:

• Material specifications: Compliance of the Ti-6Al-4V material to established standards (e.g., ASTM F136).
• Design specifications: The dimensions and geometric features of the components.
• Mechanical properties: The measured strength, stiffness, fixation integrity, and separation resistance against established performance benchmarks or comparisons to the predicate device, as determined by standardized mechanical testing methods.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML product and does not have a "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. As this is not an AI/ML device, there is no training set or ground truth established in this manner.

In summary: The submission demonstrates substantial equivalence of the "Comprehensive® Reverse Shoulder - Mini Baseplate" to its predicate device through non-clinical performance testing (e.g., compressed shear load, baseplate fixation, axial separation, torsional separation). The results of these tests confirmed that the modified device "performed within the intended use, did not raise any new safety and efficacy issues and were found to be substantially equivalent to the predicate devices." This is the primary "proof" for regulatory acceptance for this type of medical device.

Ask a specific question about this device

The Comprehensive® Reverse Shoulder is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.

The Comprehensive® Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseblate components are intended for cementless application with the addition of screw fixation.

Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

The Comprehensive® Reverse Shoulder is intended for total shoulder replacement in a reverse shoulder configuration. Unlike traditional total shoulder replacement, a reverse shoulder employs a ball for articulation on the glenoid side of the joint and a polyethylene bearing surface on the humeral side of the joint. This device configuration increases the lever arm of the deltoid muscle bundle to provide stability and the ability to raise the arm. This is especially useful in cases where a patient has a non-functioning rotator cuff which severely limits traditional joint replacement options.

The provided document is a 510(k) premarket notification for a medical device called the "Comprehensive® Reverse Shoulder Humeral Tray." It is a regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device. This type of document focuses on mechanical and material testing to show that the new device performs similarly to an already approved device, rather than conducting a study to prove a device meets specific clinical acceptance criteria in terms of diagnostic accuracy or therapeutic outcome.

Therefore, the information requested in the prompt, such as acceptance criteria based on performance metrics (e.g., sensitivity, specificity, accuracy), sample sizes for test sets (in a clinical context), ground truth establishment by experts, adjudication methods, multi-reader multi-case studies, and standalone algorithm performance, is not applicable to this document. This document describes the physical and material characteristics of an orthopedic implant and its non-clinical performance (e.g., fatigue strength, material properties).

Here's a breakdown of the relevant information from the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present acceptance criteria for diagnostic or therapeutic performance as would be relevant for an AI/algorithm-based device. Instead, it details mechanical performance comparisons to a predicate device.

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not applicable. The "tests" here refer to mechanical and material testing, not clinical data or diagnostic test sets.
• Data Provenance: Not applicable in the context of clinical data. The tests performed are laboratory-based mechanical and material characterization.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. "Ground truth" in this context would refer to material and mechanical standards defined by organizations like ASTM, not expert clinical consensus.

4. Adjudication method for the test set

• Not applicable. No clinical adjudication was performed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is not an AI/algorithm-based device. No MRMC study was conducted.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a physical medical device (shoulder implant), not an algorithm or AI.

7. The type of ground truth used

• For mechanical and material properties: Industry standards (e.g., ASTM F-648) are used to define acceptable material performance. The comparison to a legally marketed predicate device also serves as a "ground truth" for substantial equivalence.

8. The sample size for the training set

• Not applicable. This is not an AI/algorithm-based device and does not involve training data.

9. How the ground truth for the training set was established

• Not applicable.

Ask a specific question about this device

The Comprehensive® Reverse Shoulder is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.

The Comprehensive® Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation.

Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

The Comprehensive® Reverse Shoulder is intended for total shoulder replacement in a reverse shoulder configuration. Unlike traditional total shoulder replacement, a reverse shoulder employs a ball for articulation on the glenoid side of the joint and a polyethylene bearing surface on the humeral side of the joint. This device configuration increases the lever arm of the deltoid muscle bundle to provide stability and the ability to raise the arm. This is especially useful in cases where a patient has a non-functioning rotator cuff which severely limits traditional joint replacement options.

The provided document details a 510(k) premarket notification for the "Comprehensive® Reverse Shoulder - E1® Humeral Bearings." The focus of the submission is to demonstrate substantial equivalence to a predicate device, K080642, rather than to establish new safety and effectiveness through a comprehensive study meeting specific acceptance criteria as would be typical for an AI/ML device.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, expert involvement, and reader studies for a novel AI/ML device is not applicable to this document. This document pertains to a medical device (humeral bearings for shoulder replacement) that is evaluated based on material characteristics and mechanical performance, not an AI/ML algorithm.

However, I can extract information about the non-clinical tests conducted, which serve a similar purpose of demonstrating performance for this type of medical device:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission for a physical medical device, not an AI/ML algorithm, the "acceptance criteria" are implied by demonstrating equivalence to a legally marketed predicate device through non-clinical testing. The "reported device performance" refers to the results of these non-clinical tests. Specific numerical acceptance criteria are not explicitly stated as they would be for an AI/ML diagnostic's sensitivity/specificity. Instead, the performance demonstrated that the new device "performed within the intended use" and did not raise new safety or efficacy issues when compared to the predicate.

2. Sample size used for the test set and the data provenance

• Sample size: Not explicitly stated for specific tests, but generally refers to a sufficient number of test articles/specimens to perform the mechanical tests listed (e.g., multiple specimens for tensile strength, impact strength, pull-out, lever-out, and torque-out tests).
• Data provenance: Not explicitly stated, but these are material and mechanical property tests typically conducted in a laboratory setting by the manufacturer (Biomet Manufacturing Corp.) or a qualified testing facility. The data would be prospective to the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. For this type of mechanical device, "ground truth" is established by adherence to recognized ASTM standards for material and mechanical properties, not by expert consensus on clinical findings. The evaluation is based on scientific and engineering principles.

4. Adjudication method for the test set

• Not applicable. Adjudication methods like 2+1 or 3+1 are for clinical evaluations or subjective assessments, not for objective mechanical property testing against standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is a physical medical device, not an AI/ML diagnostic or assistive tool. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a physical medical device, not an AI/ML algorithm.

7. The type of ground truth used

• Non-clinical/Mechanical Performance and Material Standards: The "ground truth" for this device's performance is based on established engineering and material science standards (e.g., ASTM D-638 for tensile testing, ASTM F-648 for IZOD impact strength) and the comparative performance against the predicate device.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI/ML algorithm. There is no "training set."

9. How the ground truth for the training set was established

• Not applicable. This is a physical medical device, not an AI/ML algorithm. There is no "training set" or ground truth for one.

Ask a specific question about this device

The Comprehensive® Reverse Shoulder is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.

The Comprehensive® Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation.

Intertok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

The Comprehensive® Reverse Shoulder is intended for total shoulder replacement in a reverse shoulder configuration. Unlike traditional total shoulder replacement, a reverse shoulder employs a ball for articulation on the glenoid side of the ioint and a polyethylene bearing surface on the humeral side of the joint. The components may be used as a primary procedure or during the revision of a failed shoulder prosthesis.

For a reverse shoulder application, a Glenosphere Baseplate with a Glenosphere is implanted into the glenoid side of the joint. The Glenoid Baseplate is attached to the natural bone with the use of a Central Screw and Peripheral Screws. A Humeral Tray with natural Bearing is attached to a Comprehensive® Humeral Stem to complete the a Hameral side of the joint. The use of a standard Comprehensive® humeral component namoral olde of the form of leaving a well-fixed humeral stem from a previous total or hemi-shoulder surgery in place while still being able to convert the shoulder to a reverse configuration. It also would facilitate the conversion of a reverse configured shoulder to a hemi-shoulder in the future if the need were to arise.

This document is a 510(k) premarket notification summary for the Comprehensive® Reverse Shoulder. It primarily focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting detailed acceptance criteria and a study proving device performance against those criteria in the way one might find for a software or AI/ML device.

Therefore, many of the requested elements are not applicable or cannot be extracted directly from this type of regulatory submission. This document describes a medical device (shoulder prosthesis) and its indications for use, not a diagnostic or prognostic algorithm that would typically undergo the kind of performance studies you're asking about.

Here's an attempt to address your points based on the provided text, indicating where information is not available:

1. A table of acceptance criteria and the reported device performance

   • This information is not provided in a quantitative table format suitable for strict acceptance criteria as one would find for a software's performance metrics (e.g., sensitivity, specificity). The document focuses on demonstrating substantial equivalence to predicate devices through design, material, and intended use similarities, and non-clinical testing.
   • Acceptance Criteria (Implied for Substantial Equivalence): The device must be demonstrated to be as safe and effective as the predicate devices. This involves showing similar technological characteristics and performance through non-clinical testing.
   • Reported Device Performance: "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." No specific performance metrics (e.g., wear rates, fatigue life, range of motion under specific load, etc.) or their corresponding acceptance thresholds are detailed in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not applicable as this is a physical medical device. The "testing" mentioned is non-clinical laboratory testing (e.g., mechanical tests), not clinical studies with patient data. No "test set" in the context of patient data is described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not applicable. This is for a physical device, not an AI/ML algorithm requiring expert ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not applicable. No clinical test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   • Not applicable. This is not an AI/ML device, and no MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • For the non-clinical testing, the "ground truth" would be established engineering standards, material properties, and biomechanical principles against which the physical device components are tested. It would not typically involve expert consensus, pathology, or patient outcomes data in this context.

8. The sample size for the training set

   • Not applicable. This is not an AI/ML device, so there is no training set mentioned.

9. How the ground truth for the training set was established

   • Not applicable. As above, no training set.

Summary from the document:

The provided document, K080642, is a 510(k) summary for a physical medical device, the Comprehensive® Reverse Shoulder. For such devices, the regulatory pathway often relies on demonstrating substantial equivalence to existing, legally marketed predicate devices.

The key points regarding "performance" and "testing" from the document are:

• Non-Clinical Testing: "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use."
• Clinical Testing: "None provided as a basis for substantial equivalence."

This indicates that the manufacturer relied on laboratory tests (e.g., mechanical, material, fatigue testing) to show the device performed similarly to its predicates and met its functional requirements, rather than clinical studies with human participants. The specific acceptance criteria and detailed performance results of these non-clinical tests are not disclosed in this summary but would have been part of the full 510(k) submission.

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